| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01082-1 |
| Product Name/Description |
Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin Liners
ProcedurePak Trays:
Maxillo Facial Pack Rev4, Cairns Base Maxillo Facial Pack Rev4, Cairns Base Limb Rev6
SKU: 97006791-05, 97006791-07, 97008210-07
Batch ID: 12073320, 12080223, 12168637
Basin Liner Product Codes: 2302362-00 & 2309247-00
ARTG Numbers: 213220 & 133564 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Mölnlycke Health Care has received a recall notification from Ecolab-Microtek Medical regarding Basin Liners which are contained within ProcedurePak products. The supplier has identified that very low number of basin liners have small holes or cracks which if present may compromise sterility. |
| Recall Action |
Recall |
| Recall Action Instructions |
Molnlycke Healthcare is requesting their customers to isolate any product from the affected batches. Mölnlycke Health Care will arrange for the collection and replacement of the product. This action has been closed-out on 06/06/2016. This action has been closed-out on 06/06/2016. |
| Contact Information |
02 8977 2114 - Molnlycke Healthcare Regulatory and Quality Affairs |